Date PostedSeptember 6, 2022
Location (State / UT)
Experience10 Years, 15 Years
Desired QualificationBachelor Degree, Master’s Degree
The job holder must be responsible for overall heading the validation activity of the site which includes prior experience in sterile, non-sterile, and sex-hormone.
- To participate in the review and approval of qualification validation protocols and reports along with documents pertaining to equipment qualification and its compliance.
- Review of system-level impact assessment for validation and qualification of instruments and equipment.
- Responsible for review and approval of changes that could potentially impact any modification in facility, process, and procedures along with aseptic process validation and cleaning validation protocols.
- Follow and comply with the Quality Management System i.e. handling of deviation, investigation, CAPA, and change control with prior knowledge of EDMS & TrackWise.
- Ensure that all processing and storage areas are qualified as per GMP requirements and should be updated with the latest developments in international regulatory guidelines like FDA, MHRA, EU, TGA, etc.
- Manage, coach, and develop a high-performing quality instilled team that meets agreed objectives and which delivers best practice results, adds value, and facilitates continuous improvement.
- Extend need-based support to other DF plants along with taking ownership of varied other assignments assigned from time to time.
Education: B.Tech/B. Pharma/M. Pharma
Experience: 10 to 15 yrs of Experience in Formulation Plant (Sterile & Tablet Manufacturing)
Only Pharma Manufacturing Industries experience candidates need be apply
Assam/Nearby state candidates will be preferred